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Celldex Announces Upcoming Late Breaking Oral Presentation of 52 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EADV Congress 2024

Key Takeaway: Celldex Therapeutics announced that its abstract detailing 52-week results of the Phase 2 trial for barzolvolimab in patients with chronic spontaneous urticaria has been accepted for a late-breaking oral presentation at the EADV Congress 2024 in Amsterdam. The data is expected to showcase the drug's efficacy and safety profile. An e-poster discussing improvements in quality of life due to barzolvolimab treatment will also be available during the congress. This development highlights Celldex's ongoing efforts in advancing its pipeline for serious inflammatory conditions.

Market Sentiment Analysis

POSITIVE FACTORS

  • Barzolvolimab shows profound efficacy and favorable safety over 52 weeks in patients with Chronic Spontaneous Urticaria.
  • The acceptance of the abstract for a late-breaking oral presentation indicates strong interest in Celldex's research.
  • The presentation at a prestigious congress like EADV demonstrates recognition of the importance of the findings.

CONCERNS & RISKS

  • The clinical trial is still ongoing, which introduces uncertainties if results are replicated long-term.
  • Regulatory approval remains uncertain as the company has a limited experience in progressing to Phase 3 clinical trials.

Full Press Release Details

HAMPTON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that an abstract describing 52 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease, has been accepted as a late breaking oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2024 being held in Amsterdam on September 25-28, 2024.
Abstracts will be available on the EADV Congress website at the start of the meeting. Presentation details are as follows:
Abstract Title: Barzolvolimab shows profound efficacy and favorable safety over 52 weeks in patients with Chronic Spontaneous Urticaria
Presenting Author: Martin Metz, M.D., Professor of Dermatology and Allergy at Charité - Universitätsmedizin in Berlin
Session: D1T01.2: Late breaking news
Date/Time: Wednesday, September 25th at 16:45-17:00 CEST (10:45 – 11:00 am ET)
In addition, an e-Poster (#P3596) entitled “Barzolvolimab treatment improves quality of life and urticaria control in patients with chronic spontaneous urticaria (CSU): Results from a Phase 2 trial” will be available at EADV in the e-poster area and on the online EADV platform. These data are from the 12 week analysis.
About Celldex Therapeutics, Inc.
Celldex is a clinical stage biotechnology company leading the science at the intersection of mast cell biology and the development of transformative therapeutics for patients. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic, autoimmune and other devastating diseases. Visit www.celldex.com.
Forward Looking Statement
This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159), in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
Senior Vice President, Corporate Affairs & Administration

Frequently Asked Questions

What is the focus of Celldex's latest clinical trial?

The trial focuses on barzolvolimab for chronic spontaneous urticaria refractory to antihistamines.

When will the findings of the trial be presented?

The findings will be presented on September 25th, 2024, at the EADV Congress.

Who is the presenting author of the abstract?

Dr. Martin Metz, a Professor at Charité - Universitätsmedizin in Berlin, will present.

What additional information is available at EADV?

An e-Poster on barzolvolimab's efficacy and quality of life improvements will be available.

What type of company is Celldex Therapeutics?

Celldex is a clinical-stage biotechnology company focused on innovative therapeutics.

Last updated: Sep 16, 2024